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Prof. Dr. Karl Lauterbach MdB The “Cancer Industry” and Pharmaceutical Policy in Germany Dr. Karl Lauterbach, MD, ScD, MPH (HSPH ‘92) Professor of Health Economics and Clinical Epidemiology, University of Cologne Member of the Deutscher Bundestag Deputy Leader of the Social Democratic Parliamentary Group Author of the new book The Cancer Industry Seite 1 Prof. Dr. Karl Lauterbach MdB Probability of developing cancer in Germany in Percent Birth to Death 60 50.8 50 42.9 40 30 20 10 0 Male Source: Robert Koch-Institut, Krebs in Deutschland, 2009/2010, Berlin 2013 Seite 2 Female Prof. Dr. Karl Lauterbach MdB Probability of dying of cancer in Germany in Percent Birth to Death 30 25.8 25 22.2 20 15 10 5 0 Male Source: Robert Koch-Institut, Krebs in Deutschland, 2009/2010, Berlin 2013 Seite 3 Female Prof. Dr. Karl Lauterbach MdB Incidence rates for cancer in Germany, by gender and age (per 100,000 population) Female Male Source: Robert Koch-Institut, Krebs in Deutschland, 2009/2010, Berlin 2013 Seite 4 Prof. Dr. Karl Lauterbach MdB Estimated cumulative risk of developing cancer in Great Britain for 1960 cohort Source: A S Ahmad, N Ormiston-Smith and P D Sasieni,:Trends in the lifetime risk of developing cancer in Great Britain: comparison of risk for those born from 1930 to 1960. British Journal of Cancer (2015) 112, 943–947 Seite 5 Prof. Dr. Karl Lauterbach MdB Hallmarks of cancer Limitless replicative potential Non-cancer cells die after a certain number of divisions. Cancer cells escape this limit and are apparently capable of indefinite growth and division (immortality). Insensitivity to anti-growth signals Self-sufficiency in growth signals Sustained angiogenesis Angiogenesis is the process by which new blood vessels are formed. Cancer cells appear to be able to kickstart this process, ensuring that such cells receive a continual supply of oxygen and other nutrients Source: Hanahan D., Weinberg R.A.: "The Hallmarks of Cancer". Cell 100 (1): 57–70. (2000) and Hanahan, D.; Weinberg, R. A.: "Hallmarks of Cancer: The Next Generation". Cell 144 (5): 646–674 (2011) https://en.wikipedia.org/wiki/The_Hallmarks_of_Cancer#Limitless_replicative_potential Seite 6 Prof. Dr. Karl Lauterbach MdB Hallmarks of cancer Evading apoptosis Apoptosis is a form of programmed cell death (cell suicide), the mechanism by which cells are programmed to die in the event they become damaged. Cancer cells are characteristically able to bypass this mechanism. Tissue invasion and metastasis Cancer cells can break away from their site or organ of origin to invade surrounding tissue and spread (metastasize) to distant body parts. Evading the immune system Cancer cells appear to be invisible to the body’s immune system. Deregulated metabolism Most cancer cells use abnormal metabolic pathways to generate energy, a fact appreciated since the early twentieth century with the postulation of the Warburg hypothesis, but only now gaining renewed research interest. Source: Hanahan D., Weinberg R.A.: "The Hallmarks of Cancer". Cell 100 (1): 57–70. (2000) and Hanahan, D.; Weinberg, R. A.: "Hallmarks of Cancer: The Next Generation". Cell 144 (5): 646–674 (2011) https://en.wikipedia.org/wiki/The_Hallmarks_of_Cancer#Limitless_replicative_potential Seite 7 Prof. Dr. Karl Lauterbach MdB New cancer drugs Tyrosine kinase inhibitors Protein kinases play a crucial role in signal transduction and also in cellular proliferation, differentiation and various regulatory mechanisms. The inhibition of growth-related kinases, especially tyrosine kinases, might therefore provide new therapies for cancer. Source: Traxler P.: Tyrosine kinases as targets in cancer therapy - successes and failures. Expert Opin Ther Targets 2003 Apr;7(2):215-34 and Sebolt-Leopold J.S., English J.M.: Mechanisms of drug inhibition of signalling molecules. Nature 441, 457-462 (25 May 2006) Seite 8 Prof. Dr. Karl Lauterbach MdB New cancer drugs Monoclonal antibodies Antibodies have the unique capacity to target and kill tumor cells while simultaneously activating immune effectors to kill tumor cells through the complement cascade or antibodydependent cellular cytotoxicity (ADCC). This multifaceted mechanism of action combined with target specificity underlies the capacity of antibodies to elicit anti-tumor responses while minimizing the frequency and magnitude of adverse events. Source: Shuptrine C.W., Surana R., Weiner L.M.: Monoclonal antibodies for the treatment of cancer. Semin Cancer Biol 2012 Feb;22(1):3-13. doi: 10.1016/j.semcancer.2011.12.009. Epub 2012 Jan 8 Seite 9 Prof. Dr. Karl Lauterbach MdB New cancer drugs Checkpoint inhibitors The immune system depends on multiple checkpoints or “immunological brakes” to avoid overactivation of the immune system on healthy cells. Tumor cells often take advantage of these checkpoints to escape detection by the immune system. CTLA-4 and PD-1 are checkpoints that have been studied as targets for cancer therapy. Inhibiting a checkpoint (ie, “releasing the brakes”) on the immune system may enhance the anti-tumor T-cell response. This class of therapy has shown efficacy in cancer and clinical trials are ongoing. Source: http://www.fightcancerwithimmunotherapy.com/ImmunotherapyAndCancer/TypesOfCancerImmunotherapy.aspx and Sharma P., Wagner K., Wolchok J.D., Allison J.P.. Novel cancer immunotherapy agents with survival benefit: recent successes and next steps. Nature reviews Cancer. 2011;11(11):805-812. doi:10.1038/nrc3153. Seite 10 Prof. Dr. Karl Lauterbach MdB Number of active products in the pipeline to date = 6234 Source: IMS Institute: Global Oncology Trend Report, 2014 Seite 11 Prof. Dr. Karl Lauterbach MdB Top 10 pharmaceutical companies based on global oncology revenue in 2014 and 2020 (in million U.S. dollars) 2020 0 5000 10000 2014 Revenue in million U.S. dollars 15000 14,197 7,407 12,614 Bristol-Myers Squibb 3,833 11,314 Novartis 8,729 8,388 Pfizer 3,046 6,812 Johnson & Johnson 4,158 6,725 Astra Zeneca Eli Lilly 2,997 5,332 1,459 5,167 2,986 4,964 2,875 Source:EvaluatePharma - World Preview 2015, Outlook to 2020 Seite 12 30000 25,828 Celgene Merck & Co 25000 28,467 Roche Astellas Pharma 20000 Prof. Dr. Karl Lauterbach MdB “In the United States, the average price of cancer drugs for about a year of therapy increased from $5000 to $10,000 before 2000 to more than $100,000 by 2012, while the average household income has decreased by about 8% in the past decade. Further, although 85% of cancer basic research is funded through taxpayers’ money, Americans with cancer pay 50% to 100% more for the same patented drug than patients in other countries.” Hagop Kantarjian, MD, and S. Vincent Rajkumar, MD Source:Mayo Clin Proc. 2015;90(4):500-504 Seite 13 Prof. Dr. Karl Lauterbach MdB Five charges against drug companies 1: The high prices of cancer drugs don‘t correlate with their benefits. 2: The high prices don‘t result from research and development but serve only the profit interests of the companies. Seite 14 Prof. Dr. Karl Lauterbach MdB Five charges against drug companies 3: The companies misuse their market power. 4: The pharmaceutical companies often obstruct research. 5: The high drug prices will burst the healthcare systems. Seite 15 Prof. Dr. Karl Lauterbach MdB Pay for benefit the AMNOG in Germany Seite 16